Serological response to Hepatitis B: Geometric mean of anti-HBs,percentage of infants with titer >=10mlIU/ml, percentage of infants with increasing antibody titer >=4 times and/ or percentage of infants with transition of seronegative to seropositive.

Serological response to Hib/PRP: GMT, percentage of infants with titre >=1ug/ml and >=0.15ug/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive

This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.

Eligibility

Ages Eligible for Study:

6 Weeks to 11 Weeks

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Infant 6-11 week of age

Infant born after 37-42 week of pregnancy

Infant weighting more than 2.5 kg at birth

Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form

Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial

Known history of allergy to any component of the vaccine component (e.g.formaldehyde)

History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection

Known history of congenital or acquired immunodeficiency (including HIV infection)

Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 weeks)

Other vaccination within the 1 month prior to inclusion with the exception of BCG and poliomyelitis

Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective

Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986335